Pancreatic CancerNCT03809247
Microbial Diversity of Pancreatic Diseases
An observational study of Pancreatic Cancer and Pancreatic Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
This study plans to analyze the digestive flora structure of the group of patients with pancreatic cancer. The investigators compared the microflora of pancreatic cancer with other pancreatic diseases and healthy people，in order to obtatin the information of microbial community difference among the different groups. Read more about this study
- Who is it for?
- Ages 3 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Disease
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Male / Female Age ≥ 3 years old, ≤ 85 years old; * After MDT discussion, routine surgery can be performed, and the postoperative pathology is clear as pancreatic cancerand other pancreatic diseases; * No history of antibiotics for three months before surgery, no history of yogurt containing probiotics. * There is no serious damage to heart, liver and kidney function. * After obtaining the consent and specimen collection, detailed screening found that some cases with history of antibiotics or yogurt history in three months. This part of the specimen was not discarded. As a second candidate research objects to study the effect of antibiotics or yoghurt on the flora in the disease state.
Who may be able to join
- Age ≥ 3 years old, ≤ 85 years old;
- After MDT discussion, routine surgery or ERCP can be performed, and the postoperative pathology is clear as pancreatic cancer and other pancreatic diseases;
- There is no serious damage to heart, liver and kidney function;
Who cannot join
- Women who are breast-feeding during pregnancy and after pregnancy;
- Patients with evidence of sensory or motor neuropathy;
- Those who have a clear cardiovascular disease, severe associated disease or active infection, including known HIV infection;
- Those who have a history of other cancers;
- Those who are allergic to drugs or their excipients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Wei Wang, +86-13761648121, wangwei_0306@163.com
About this study
This study plans to analyze the digestive flora structure of the group of patients with pancreatic cancer.
The investigators compared the microflora of pancreatic cancer with other pancreatic diseases and healthy people，in order to obtatin the information of microbial community difference among the different groups. Finally，the investigators hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.
Read the detailed description
First, all the participants provided written informed consent for participating in the study. And the collecting procedures have no intervention or impact on treatment measures.
Second,the samples are collected, including the stools, the peripheral blood, and other digestive secretions. If the participants had surgical indications and received surgical treatment, the surgical resections of tissues (including paraffin section) are also collected.
Third, the participants were basically divided into three groups，cases with pancreatic cancer, cases with other pancreatic diseases, and health volunteers.
Finally, the investigators compare the microflora , its metabolites or effects among the different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues ( (including paraffin section)) and so on, and hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.
- Conditions
- Pancreatic Cancer, Pancreatic Disease
- Keywords
- Pancreatic cancer, Pancreatic Disease
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
Also called have no any intervention
have no any intervention
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic cancer | such as Pancreatic ductal adenocarcinoma, Pancreatic acinar adenocarcinoma, and so on. | |
| Other pancreatic diseases | such as chronic pancreatitis, Intraductal papillary mucinous neoplasm (IPMN); Solid pseudopapillary tumors (SPT); Serous cystic neoplasm (SCN); Pancreatic neuroendocrine neoplasm (P-NN); Mucinous cystic neoplasm (MCN) and so on. |
What is being measured
The primary outcome is the main question the study is designed to answer.
16sRNA and metagenomics
Obtain intestinal microbial information from patients with pancreatic cancer and other pancreatic diseases, and obtain information on microbial community structure, evolutionary relationships, and microbial and environmental correlations in intestinal environment samples(weight in grams).
Correlate the patient's microbial profile with the pathogenesis of the patient to obtain biomarkers related to the pathogenesis.
Measured: 12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Feb 2019
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WeiWang, Ruijin Hospital
- Investigators
- Wei WANG, Dr., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809247
- Sponsor's protocol ID
- pancreatic diseases
- Status last verified
- Jun 2023
- First submitted
- 24 Dec 2018
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Diversity of Pancreatic Diseases
- ClinicalTrials.gov ID
- NCT03809247
- Acronym / sponsor ID
- pancreatic diseases
- Conditions
- Pancreatic Cancer, Pancreatic Disease
- Keywords
- Pancreatic cancer, Pancreatic Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to analyze the digestive flora structure of the group of patients with pancreatic cancer.
The investigators compared the microflora of pancreatic cancer with other pancreatic diseases and healthy people，in order to obtatin the information of microbial community difference among the different groups. Finally，the investigators hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.
Detailed description
First, all the participants provided written informed consent for participating in the study. And the collecting procedures have no intervention or impact on treatment measures.
Second,the samples are collected, including the stools, the peripheral blood, and other digestive secretions. If the participants had surgical indications and received surgical treatment, the surgical resections of tissues (including paraffin section) are also collected.
Third, the participants were basically divided into three groups，cases with pancreatic cancer, cases with other pancreatic diseases, and health volunteers.
Finally, the investigators compare the microflora , its metabolites or effects among the different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues ( (including paraffin section)) and so on, and hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic cancer | – | –such as Pancreatic ductal adenocarcinoma, Pancreatic acinar adenocarcinoma, and so on. |
| Other pancreatic diseases | – | –such as chronic pancreatitis, Intraductal papillary mucinous neoplasm (IPMN); Solid pseudopapillary tumors (SPT); Serous cystic neoplasm (SCN); Pancreatic neuroendocrine neoplasm (P-NN); Mucinous cystic neoplasm (MCN) and so on. |
Who may qualify
- Ages
- 3 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male / Female Age ≥ 3 years old, ≤ 85 years old; * After MDT discussion, routine surgery can be performed, and the postoperative pathology is clear as pancreatic cancerand other pancreatic diseases; * No history of antibiotics for three months before surgery, no history of yogurt containing probiotics. * There is no serious damage to heart, liver and kidney function. * After obtaining the consent and specimen collection, detailed screening found that some cases with history of antibiotics or yogurt history in three months. This part of the specimen was not discarded. As a second candidate research objects to study the effect of antibiotics or yoghurt on the flora in the disease state.
Key inclusion criteria (3 listed)
- Age ≥ 3 years old, ≤ 85 years old;
- After MDT discussion, routine surgery or ERCP can be performed, and the postoperative pathology is clear as pancreatic cancer and other pancreatic diseases;
- There is no serious damage to heart, liver and kidney function;
Key exclusion criteria (5 listed)
- Women who are breast-feeding during pregnancy and after pregnancy;
- Patients with evidence of sensory or motor neuropathy;
- Those who have a clear cardiovascular disease, severe associated disease or active infection, including known HIV infection;
- Those who have a history of other cancers;
- Those who are allergic to drugs or their excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Also: have no any interventionhave no any intervention | Other | Other pancreatic diseases, Pancreatic cancer |
Primary outcome
16sRNA and metagenomics
Time frame: 12/2022
Obtain intestinal microbial information from patients with pancreatic cancer and other pancreatic diseases, and obtain information on microbial community structure, evolutionary relationships, and microbial and environmental correlations in intestinal environment samples(weight in grams). Correlate the patient's microbial profile with the pathogenesis of the patient to obtain biomarkers related to the pathogenesis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei WANG, Dr. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Pancreatic Disease, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei WANG, Dr. (+86-13761648121 ext. 671001, wangwei_0306@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16sRNA and metagenomics (time frame: 12/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.